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ContraceptionZim CHICNCT02038335

HIV-Target Cell Response in Women Initiating Various Contraceptive Methods in High HIV-Incidence Areas: Zim CHIC

An observational study of Contraception and HIV, run by University of Pittsburgh at 1 site in Zimbabwe.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is being done to understand if using birth control causes changes in the immune cells within the reproductive tract of healthy women. Immune cells are important because they help prevent infections from starting and help fight infections that have started. Read more about this study

Who is it for?
Ages 18 to 34 years, women only
What is being tested?
DMPA, NET-EN and MPA/E2
Type of treatment
Medical device
How many people
451 participants
Where
1 siteZimbabwe
Study dates
Feb 2014to Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 34 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: Healthy women, age 18-34 years, who are HIV negative and non-pregnant.

Who may be able to join

  • Age 18 through 34 years (inclusive) at screening
  • Non-pregnant women in general good health as determined by the site clinician
  • Premenopausal with history of regular menstrual cycles (regular cycles defined as occurring every 21-35 days when not using hormones and with a variation of typical cycle length of no more than 5 days)
  • Able and willing to provide written informed consent to be screened for and to take part in the study. Including willingness to undergo all study-related assessments and follow all study-related procedures
  • Able and willing to provide adequate locator information
  • HIV-uninfected based on testing performed by study staff at screening
  • At screening and enrollment, agrees not to participate in other research studies involving drugs, medical devices, or vaginal products while enrolled in this trial

Who cannot join

  • Use of any hormonal or intrauterine contraceptive method within 30 days of enrollment
  • Use of DMPA or NET-EN within 10 months of enrollment
  • Pregnancy or breastfeeding within 60 days of enrollment
  • Surgical procedure involving the pelvis in the 30 days prior to enrollment (includes dilation and curettage, cryosurgery and biopsy of the vagina, vulva, cervix, and endometrium)
  • Internal vaginal use of any device (includes sex toys, cervical caps, diaphragms, menstrual collection devices, and pessaries; excludes tampons and condoms) or product (includes N9, microbicide, douche, antifungal, steroid, or hormone) in the 30 days prior to enrollment
  • New sexual partner within 90 days of enrollment
Show all 17Show fewer
  • Urogenital infection or suspected infection within 30 days of enrollment including:
  • symptomatic candidiasis, trichomoniasis, and symptomatic BV; or cervical infection, including N. gonorrhoeae, Chlamydia trachomatis, or mucopurulent cervicitis; syphilis; HSV lesions, or other sores (Note: seropositive HSV without active lesions will not be excluded); acute pelvic inflammatory disease; urinary tract infection; recent exposure to a partner with GC, CT, Trichomonas, syphilis, or NGU. Women who have had diagnosed genital infections should have completed treatment at least 30 days before the time of enrollment.
  • Any history of immunosuppression (includes diabetes, HIV infection, and chronic steroid use)
  • Antibiotic or antifungal therapy (vaginal or systemic) within 30 days of enrollment
  • Menses or other vaginal bleeding at the time of Enrollment* (*Women who have vaginal bleeding at the scheduled Enrollment Visit may return at a different date to be re-examined and possibly enrolled provided they are still within the 90-day screening window and meet all criteria).
  • Vaginal or anal intercourse within 2 days (48 hours) prior to enrollment
  • Heterosexual intercourse since last menses that places the participant at risk of pregnancy (without condom use or sterilization of at least one partner)
  • History of hysterectomy
  • History of malignancy within the pelvis (includes uterus, cervix, vagina, and vulva)
  • Contraindication, allergy or intolerance to use of the contraceptive desired by the participant
  • Any condition that, in the opinion of the Investigator, would preclude provision of consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives

Trial locations and contacts

1 site in 1 country.

Zimbabwe1 site

  • UZ UCSF

    Harare

Other trials in Zimbabwe

About this study

This study is being done to understand if using birth control causes changes in the immune cells within the reproductive tract of healthy women. Immune cells are important because they help prevent infections from starting and help fight infections that have started. Immune cells are also the type of cells that HIV (human immunodeficiency virus) infects so understanding more about them will help to better understand how to prevent the spread of HIV.

Immune cells will be studied from the reproductive tract of women who want to start using one of the following contraceptives: Depo-Provera (DMPA), NET-EN, MPA/E2 (Cyclofem®), the levonorgestrel subdermal implant (Jadelle® ), the etonogestrel subdermal implant (Implanon® or Nexplanon® ) and the copper IUD.

Being tested
DMPA, NET-EN, MPA/E2, LNG-I, ENG-I
Keywords
immune cells, contraception, intrauterine device, IUD, copper, microbiota, DMPA, etonogestrel, subdermal implant, NET-EN, Jadelle, Implanon, Cyclofem

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DMPADrug

    Also called Depot medroxyprogesterone acetate (DMPA)

    Depot medroxyprogesterone acetate

  • NET-ENDrug

    Also called Norethisterone enantate (NET-EN)

    Norethisterone enantate

  • MPA/E2Drug

    Also called Medroxyprogesterone acetate and estradiol cypionate (MPA/E2)

    Medroxyprogesterone acetate and estradiol cypionate

  • LNG-IDevice

    Also called Levonorgestrel subdermal implant (LNG-I)

    Levonorgestrel subdermal implant

  • ENG-IDevice

    Also called Etonogestrel subdermal implant (ENG-I)

    Etonogestrel subdermal implant

  • Cu-IUDDevice

    Also called Copper IUD (Cu-IUD)

    Copper IUD

Study groups in NCT02038335
Study groupRoleWhat they receive
DMPADepot medroxyprogesterone acetate
Receives: Drug: DMPA
NET-ENNorethisterone enantate
Receives: Drug: NET-EN
MPA/E2Medroxyprogesterone acetate and estradiol cypionate
Receives: Drug: MPA/E2
LNG-ILevonorgestrel subdermal implant
Receives: Device: LNG-I
ENG-IEtonogestrel subdermal implant
Receives: Device: ENG-I
Cu-IUDCopper IUD
Receives: Device: Cu-IUD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Genital tract CD4 cells (number and % expressing CCR5)

    To quantify and characterize immune cell populations and HIV-tropic receptor expression in the genital tract and blood at baseline and after 1, 3 and 6 months of typical contraceptive use. Immune cell populations will be quantified and characterized using flow cytometry.

    Measured: Change from baseline at 3 months

Secondary outcomes (3)

  1. Vaginal microbiota (key microbes)

    To describe the microflora of the genital tracts of healthy asymptomatic women before and after 1, 3 and 6 months of typical contraceptive use and to assess changes in the vaginal ecology within the first 6-months of contraceptive use. qPCR for key microflora and Nugent scores will be used.

    Measured: Change from baseline at 3 months

  2. Serum hemoglobin

    To objectively assess blood count before and at 1,3,and 6 months following initiation of each contraceptive method. Standard clinical complete blood count (CBC) will be obtained at each visit.

    Measured: Change from baseline at 6 months

  3. Serum concentration of estradiol and progesterone/progestin

    To assess relative serum concentrations of endogenous and exogenous sex hormones before and after contraceptive use. Hormonal concentrations will be assessed by measuring blood levels of estrogen and progesterone as well as blood levels of the contraceptive progestin corresponding to the cohort group for that participant.

    Measured: Change from baseline at 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionJun 2016
  4. Study completionDec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
451 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02038335
Sponsor's protocol ID
PRO13080550
Acronym
Zim CHIC
Status last verified
Dec 2020
First submitted
8 Jan 2014
Last updated
3 Dec 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Achilles SL, Meyn LA, Mhlanga FG, Matubu AT, Stoner KA, Beamer MA, Chirenje ZM, Hillier SL. Zim CHIC: A cohort study of immune changes in the female genital tract associated with initiation and use of contraceptives. Am J Reprod Immunol. 2020 Sep;84(3):e13287. doi: 10.1111/aji.13287. Epub 2020 Jun 25.

    PubMed 32533883

Questions about this trial

What is this clinical trial studying?

An observational study of Contraception and HIV, run by University of Pittsburgh at 1 site in Zimbabwe.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Genital tract CD4 cells (number and % expressing CCR5) (time frame: Change from baseline at 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02038335, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2020.

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